Abstracts

RATIONALE: Pregabalin (PGB) is a derivative of GABA which has been shown to possess anticonvulsant properties.Statistically significant reduction in seizure has been demonstrated in a multicenter double-blind controlled add-on clinical trial. This reports summarizes open clinical experience with PGB. METHODS: Patients were entered into this protocol to obtain information on long term safety. They were either completing a double-blind controlled efficacy trial or were patients having at least 2 complex partial seizures per month and PGB was added to improve seizure control. The AEDs and did not have a significant progressive medical or psychiatric disorder. Baseline seizure frequency was prospectively collected for 56 days before starting PGB. Doses of concurrent AEDs were not changed during baseline but could be reduced or discontinued during treatment with PGB depending on change in seizure frequency. Patients were seen at 4-12 week intervals, at which time report of adverse events (AEs), neurological exam, vital signs, serum chemistries, CBC and AED levels were obtained. RESULTS: Thirty six patients have received open treatment with PGB for up to 60 weeks with doses ranging from 100 to 600 mg/day. During baselin, patients were receiving one (n=12), two (n=20) or three (n=4) AEDs. Thirteen patients are maintained long term on 600 mg/day. Six patients have dropped, lack of efficacy (4 patients), patient preference (1 patient) and 1 patient died as a result of a convulsion. Thirty patients are still on PGB. Group demographics include mean are of 41.5 yrs (22-57), average of 22.2 years with seizures (2-42 years), and include 14 females/22males. No adverse effects were reported by 17 patients. Most frequent AEs included dizziness, ataxia, sleepiness and weight gain. Elevated CK values were noted in 3 patients who were asymptomatic. Average change in seizures across all patients was -30% with 35.3% having a greater than 50% overall reduction in seizures. CONCLUSION: PGB, in doses up to 600 mg/day, is very effective and well tolerated in patients with partial seizures.